| { |
| "trial_id": { |
| "type": "string", |
| "description": "Unique trial identifier string" |
| }, |
| "n_participants": { |
| "type": "integer", |
| "description": "Total randomized participants (100\u201350000)", |
| "range": [ |
| 100, |
| 50000 |
| ] |
| }, |
| "trial_phase": { |
| "type": "string", |
| "description": "I | II | III | IV" |
| }, |
| "blinding": { |
| "type": "string", |
| "description": "OPEN | SINGLE | DOUBLE" |
| }, |
| "randomization": { |
| "type": "string", |
| "description": "SIMPLE | BLOCK | STRATIFIED | MINIMIZATION" |
| }, |
| "n_sites": { |
| "type": "integer", |
| "description": "Number of investigator sites (5\u2013200)" |
| }, |
| "arms": { |
| "type": "array", |
| "description": "List of arm objects: {arm_id, label, randomization_weight, treatment_effect_cohens_d, ae_multiplier}" |
| }, |
| "therapeutic_area": { |
| "type": "string", |
| "description": "Cardiology | Oncology | Neurology | Metabolic | Respiratory | Psychiatry | Rheumatology | Infectious Disease | Rare Disease | Ophthalmology | Dermatology | GI" |
| }, |
| "endpoint_type": { |
| "type": "string", |
| "description": "CONTINUOUS | BINARY | TTE" |
| }, |
| "endpoint_name": { |
| "type": "string", |
| "description": "Human-readable endpoint label" |
| }, |
| "baseline_mean": { |
| "type": "float", |
| "description": "Mean baseline endpoint value (CONTINUOUS only)" |
| }, |
| "baseline_sd": { |
| "type": "float", |
| "description": "SD of baseline endpoint (CONTINUOUS only)" |
| }, |
| "placebo_change_mean": { |
| "type": "float", |
| "description": "Mean CFB for placebo arm at primary visit (CONTINUOUS only)" |
| }, |
| "binary_baseline_response_rate": { |
| "type": "float", |
| "description": "Placebo response probability (BINARY only, 0\u20131)" |
| }, |
| "binary_odds_ratios": { |
| "type": "array", |
| "description": "Odds ratios vs placebo per arm (BINARY only)" |
| }, |
| "tte_median_placebo_weeks": { |
| "type": "float", |
| "description": "Median survival weeks in placebo (TTE only)" |
| }, |
| "tte_hazard_ratios": { |
| "type": "array", |
| "description": "Hazard ratios vs placebo per arm (TTE only, <1 = benefit)" |
| }, |
| "dropout_mcar_rate": { |
| "type": "float", |
| "description": "Base MCAR dropout probability per visit (0\u20130.05)" |
| }, |
| "dropout_mar_arm_coef": { |
| "type": "float", |
| "description": "Logit coefficient for arm index in MAR dropout model" |
| }, |
| "ae_base_rate_per_patient": { |
| "type": "float", |
| "description": "Expected AEs per placebo patient" |
| }, |
| "ae_active_arm_increment": { |
| "type": "float", |
| "description": "Additional AEs per active arm step above placebo" |
| } |
| } |
